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| Sponsor: | Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD) |
|---|---|
| Information provided by: | National Institutes of Health Clinical Center (CC) |
| ClinicalTrials.gov Identifier: | NCT00556400 |
Purpose
This study will explore the role of oral contraceptive pills in managing uterine bleeding in women who have low blood platelet counts as a result of aplastic anemia. Oral contraceptive pills have been shown to be effective in managing uterine bleeding in healthy women, but the effects have not been thoroughly studied in women who have low platelet counts. The purpose of the study is to determine whether oral contraceptive pills are a useful complement to platelet transfusions in women with aplastic anemia and uterine bleeding.
Volunteers for this study must be women between 12 and 55 years of age who have been diagnosed with aplastic anemia (with a platelet count of less than 50,000/microl) and currently have active uterine bleeding. Candidates must not be pregnant or breastfeeding, must have a uterus and at least one functioning ovary, and must be willing to use nonhormonal methods of birth control (such as condoms or a diaphragm) for the duration of the study. On the first visit, candidates will be screened with a complete medical history (including obstetric and gynecological history) and will undergo a physical examination, a pelvic exam and a pelvic ultrasound. Blood and urine samples will also be taken on this first visit.
The study will last approximately two weeks. Participants will be asked to monitor their medication doses and severity of bleeding during the course of the study. After the first visit, participants will be separated into two randomized groups and will receive either one tablet of oral contraceptive or a placebo twice daily, to be taken 12 hours apart at the same times each day. Participants will also receive platelet transfusions as needed to ensure that their platelet counts remain over 20,000/microl. After seven days, researchers will assess participants' uterine bleeding and all participants will be given oral contraceptives in the second week of the study. Participants whose bleeding has decreased will receive only one tablet; participants who still have moderate to severe uterine bleeding will receive two tablets. A final assessment will be performed on day 14 of the study.
| Condition | Intervention | Phase |
|---|---|---|
|
Aplastic Anemia Menorrhagia Amenorrhea |
Drug: Lo-Ovral Oral Contraceptive Pills |
Phase I Phase II |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Parallel Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | Treatment of Menorrhagia in Women With Thrombocytopenia: Comparison of Platelet Transfusion Alone to Platelet Transfusion With Continuous Oral Contraceptive Pills |
| Estimated Enrollment: | 42 |
| Study Start Date: | November 2007 |
| Estimated Study Completion Date: | July 2014 |
| Estimated Primary Completion Date: | July 2014 (Final data collection date for primary outcome measure) |
Low platelet counts can occur as a result of blood diseases like bone marrow failure, or from undergoing procedures such as chemotherapy treatment or stem cell transplantation. A major complication of low platelet counts in reproductive aged women is uterine bleeding, which can be life threatening. Sometimes this bleeding begins with a normal menstrual cycle but may start unexpectedly. In either instance, stopping uterine bleeding not only requires blood products including platelets but also hormonal treatments.
The hormones estrogen or progesterone can aid in this setting presumably by promoting endometrial angiogenesis. Continuous oral contraceptive pills (OCP) have been shown to be very effective in the management of heavy menstrual bleeding in healthy women, but few studies have been carried out in women with low platelet counts. Moreover, they have few side-effects and are contraceptive. High-dose intravenous Premarin is also useful but only for a couple of days after which heavy bleeding will ensue. Progestin hormones are similarly effective and are also contraceptive.
Oral contraceptive pills are routinely used to control uterine bleeding in thrombocytopenia secondary to bone marrow failure, chemotherapy and/or stem cell transplantation, during episodes of severe thrombocytopenia. There are no current data supporting whether the use of hormonal management is necessary in addition to platelet transfusion. We expect to show that using continuous OCP in addition to having platelet transfusions will result in a better and more rapid control of uterine bleeding than having platelet transfusions only.
Eligible subjects will be hemodynamically stable, menstruating women aged 12-55, who have bone marrow failure, or are undergoing chemotherapy and/or stem cell transplantation for other diseases with platelet levels less than 50,000 microliters and present with heavy menstrual bleeding which is expected to last at least 2 weeks. Subjects will be randomized to either continuous OCP (Lo-ovral) 1 tablet twice daily or placebo twice daily for one week. All subjects will receive platelet transfusions to keep platelet levels above 20,000 microliters throughout the study. After one week, all subjects who continue to bleed will receive continuous OCP 1 tablet twice daily. Those who have stopped bleeding will receive continuous OCP 1 tablet daily. Treatments will be compared for the proportion who stop vaginal bleeding 7 and 14 days after starting treatment.
Eligibility| Ages Eligible for Study: | 12 Years to 55 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Women aged 12-55 years who have a uterus and at least one functioning ovary.
Women with any active uterine bleeding more than spotting
Diagnosed with bone marrow failure, and other disease that require treatment with chemotherapy or stem cell transplantation with platelet counts less than 50,000 microliters at study entry
Do not desire pregnancy for the duration of the study.
Willing and able to give informed consent.
Willing and able to comply with study requirements.
EXCLUSION CRITERIA:
Age less than 12 years
Postmenopausal women
Hormone level in menopausal range: FSH greater than 40 IU/L, E (2) less than 20 pg/ml
History of liver disease that precludes OCP use
History of thrombosis, thromboembolism and/or thrombophilia.
Currently on 2 or more tablets of any oral contraceptive pills per day at study entry
Having 2 or more DMPA injections in the past 12 months or having DMPA injection in the past 90 days
Leuprolide acetate injection in the past 30 days
Smoker over the age of 35
Women with estrogen dependent tumor e.g. breast cancer.
Pregnancy.
Underlying sickle cell anemia
Women who are taking chemotherapeutic agents known to cause ovarian failure such as alkylating agents
Allergy to any medication in this protocol
Contacts and Locations| Contact: Patient Recruitment and Public Liaison Office | (800) 411-1222 | prpl@mail.cc.nih.gov |
| Contact: TTY | 1-866-411-1010 |
| United States, Maryland | |
| National Institutes of Health Clinical Center, 9000 Rockville Pike | Recruiting |
| Bethesda, Maryland, United States, 20892 | |
| Sub-Investigator: Patient Recruitment and Public Liaison Office (PRPL) For more information at the NIH Clinical Center contact | |
More Information
| Responsible Party: | Pamela Stratton, M.D./National Institute of Child Health and Human Development, National Institutes of Health |
| ClinicalTrials.gov Identifier: | NCT00556400 History of Changes |
| Other Study ID Numbers: | 080022, 08-CH-0022 |
| Study First Received: | November 9, 2007 |
| Last Updated: | December 22, 2011 |
| Health Authority: | United States: Federal Government |
|
Uterine Bleeding Thrombocytopenia Aplastic Anemia Oral Contraceptive Pills Menorrhagia |
|
Amenorrhea Anemia Anemia, Aplastic Menorrhagia Thrombocytopenia Menstruation Disturbances Pathologic Processes Hematologic Diseases Bone Marrow Diseases Uterine Hemorrhage Uterine Diseases |
Genital Diseases, Female Blood Platelet Disorders Contraceptive Agents Contraceptives, Oral Contraceptives, Oral, Combined Reproductive Control Agents Physiological Effects of Drugs Pharmacologic Actions Therapeutic Uses Contraceptive Agents, Female |
